Short Answer: A CPSR (Cosmetic Product Safety Report) is the mandatory safety assessment document required for every cosmetic product sold in the UK or EU. It’s prepared by a qualified safety assessor, confirms the product is safe for its intended use, and is a legal precondition for CPNP/SCPN notification. Without one, a product cannot be legally placed on the market.
What Does CPSR Stand For?
CPSR stands for Cosmetic Product Safety Report. It’s the formal safety assessment document required under:
- EU: Regulation (EC) No 1223/2009, Article 10 and Annex I
- UK: The UK Cosmetics Regulation (the retained version of 1223/2009), enforced via the Cosmetic Products Enforcement Regulations 2013
Why Is a CPSR Legally Required?
Both the EU and UK require every cosmetic product to be demonstrably safe before it reaches consumers. The Responsible Person — whether that’s you, your manufacturer, or your appointed representative — cannot legally place a product on the market without a completed CPSR confirming the formulation, exposure conditions, and toxicological profile have been assessed by a qualified professional.
UK vs EU Responsible Person covers who’s actually accountable for getting this done.
What’s Included in a CPSR?
A CPSR has two parts, set out in Annex I of Regulation (EC) No 1223/2009:
Part A — Cosmetic Product Safety Information
- Full quantitative and qualitative formula (including the INCI list
- Physical/chemical characteristics and stability data
- Microbiological quality
- Impurities, trace substances, and packaging material information
- Normal and reasonably foreseeable use
- Exposure calculation
- Toxicological profile for each ingredient
- Undesirable effects and serious undesirable effects (if any are known)
Part B — Cosmetic Product Safety Assessment
- The assessor’s professional conclusion
- Margin of Safety (MoS) calculations
- A final safety statement
- Labelling warnings required as a result of the assessment
- Assessor’s credentials, reasoning, and signature
Who Can Write a CPSR?
Only a qualified safety assessor can sign off a CPSR — someone holding a university-level qualification in pharmacy, toxicology, medicine, or a related discipline recognised as equivalent. A CPSR prepared or signed by someone without this qualification isn’t valid, regardless of how thorough it looks.
How Long Does a CPSR Take?
Typical turnaround is 2–4 weeks once all formulation and testing data is available. This extends if additional testing — stability, microbiological, preservative efficacy (challenge testing), or packaging compatibility — still needs to be commissioned first.
How Much Does a CPSR Cost?
Pricing depends on product complexity, ingredient count, and whether supporting tests are already available. see our full pricing breakdown for a detailed cost table by product type.
Do I Need a CPSR?
You need a CPSR if you’re a brand owner, importer, or Responsible Person selling any of the following in the UK or EU:
- Skincare — creams, serums, lotions
- Haircare products
- Makeup and colour cosmetics
- Personal care — soap, deodorant, oral care
- Niche or handmade products — see Do I Need a CPSR for Handmade Soap UK? and Do I Need a CPSR for Beard Oil UK? for category-specific answers
- Private label and white label ranges — see CPSR for Private Label Cosmetics
There is no small-business or handmade exemption in either the UK or EU — the requirement applies regardless of your production scale.
What Happens If You Sell Without One?
Selling a cosmetic product without a valid CPSR is a breach of Article 10 of the Cosmetics Regulation. Consequences can include:
- Product removal from sale / marketplace listing suspension
- Fines and Trading Standards enforcement action
- Suspension of your Responsible Person status
- Products seized at customs or port of entry
CPSR vs PIF vs TRA: What’s the Difference?
These three terms get confused constantly:
- CPSR — the safety assessment document itself
- PIF (Product Information File) — the complete regulatory dossier, of which the CPSR is one component. See Cosmetic Product Information File (PIF): Complete Guide
- TRA (Toxicological Risk Assessment) — a narrower ingredient-level risk assessment, sometimes confused with a full CPSR. See CPSR vs Toxicological Risk Assessment (TRA): What’s the Difference? for the full breakdown.
Common Reasons CPSRs Get Rejected
Even a completed CPSR can be turned back by a Responsible Person or regulator if it’s missing key data. See our full breakdown covers the most common causes, including incomplete toxicological data and missing stability results.
Frequently Asked Questions
Can I write my own CPSR if I’m not a toxicologist?
No. A CPSR must be prepared and signed by a qualified safety assessor holding a recognised qualification in toxicology, pharmacy, medicine, or an equivalent discipline. A self-written safety statement isn’t legally valid, even if it covers the same ground.
Is one CPSR valid for both the UK and EU?
Not automatically. Since Brexit, the UK and EU operate separate notification systems (SCPN and CPNP) and separate Responsible Person requirements. A CPSR prepared for one market generally needs to be reviewed — and your Responsible Person appointed — separately for the other.
Does a CPSR expire?
A CPSR doesn’t have a fixed expiry date, but it must be kept up to date. If the formulation changes, new safety data emerges, or regulations affecting an ingredient change (such as an SCCS-driven restriction), the CPSR must be reviewed and updated accordingly.
Do I need a separate CPSR for every shade or variant?
Not always — variants sharing a base formulation (like lipstick shades) can often be assessed together under a single consolidated CPSR, provided each variant’s specific ingredients are still individually evaluated.
Regulatory Sources
UK Cosmetic Products Enforcement Regulations 2013 — Chapter III: Safety Assessment (GOV.UK)
